Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation
Efficacy of Digital Sedation Compared With Neuroleptanalgesia in Percutaneous Outpatient Surgery for Superficial Venous Insufficiency
GCS Ramsay Santé pour l'Enseignement et la Recherche
400 participants
Nov 20, 2023
INTERVENTIONAL
Conditions
Summary
Virtual reality has been shown to reduce the pain experienced during medical procedures. The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.
Eligibility
Inclusion Criteria3
- Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).
- Outpatients with superficial venous insufficiency for which a surgical indication has been given
- Patient requiring sedation associated with local anesthesia
Exclusion Criteria7
- Contraindication to local anesthesia or any of the sedatives used in the protocol
- Hearing or visual impairment contraindicating use of the virtual reality headset
- Pregnant or breast-feeding patients
- Unbalanced epilepsy
- Patients under court protection, guardianship or curatorship
- Patients not affiliated to the French social security system
- Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
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Interventions
use of a device incorporating virtual reality software
Usual neuroleptanalgesic treatment
Locations(2)
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NCT06228365